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Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland facility.
Emergent BioSolutions agreed with an FDA request that the company not initiate manufacturing of new drug substance for COVID-19 vaccines and to quarantine existing material manufactured at the company’s Bayview, Md., facility. Production is halted pending the completion of an FDA inspection and any required remediation, according to Emergent’s April 19, 2021 filing (PDF) with the US Securities and Exchange Commission (SEC).
Emergent reported that it agreed to the halt in manufacturing on April 16, 2020; FDA initiated an inspection of the facility on April 12, 2021. The inspection follows the announcement of a manufacturing error at the Bayview facility that led to the loss of 15 million potential doses of Johnson & Johnson’s COVID-19 vaccine.
On April 3, Johnson & Johnson announced that it assumed responsibility for manufacturing the drug substance for its live viral vector vaccine at the Bayview facility.
Source: Emergent BioSolutions (PDF)